dye-free children's loratadine chewable tablets usp, 5 mg

Drug Facts

Composition & Product

Active Ingredients

loratadine (5 mg)

Inactive Ingredients

aspartame anhydrous citric acid silicon dioxide magnesium stearate mannitol microcrystalline cellulose sodium starch glycolate type a potato stearic acid

Identifiers & Packaging

Pill Appearance

Imprint: 106 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

anda active Since 2020-09-01

Medication Information

Active Ingredient

Loratadine USP, 5 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Purpose

Antihistamine

Directions

chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

Inactive Ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Description

Drug Facts

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel 5 Mg Tablet Blister Pack Carton

FREE

FROM

DYE FREE

24 HOUR

NDC 11822-8329-7

Compare to the active

ingredient of Children's

Claritin^® Chewables**

AGES 2 YEARS & OLDER

CHILDREN'S

ALLERGY RELIEF

CHEWABLE TABLETS • ANTIHISTAMINE

DYE-FREE

LORATADINE CHEWABLE TABLETS USP, 5 mg

NON-DROWSY* INDOOR / OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose • Itchy, watery eyes

Itchy throat or nose

ACTUAL SIZE

GRAPE

FLAVOR

30

CHEWABLE TABLETS

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING.

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Loratadine USP, 5 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Purpose

Antihistamine

Directions

chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information (Other information)

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

Inactive Ingredients (Inactive ingredients)

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel 5 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton)

FREE

FROM

DYE FREE

24 HOUR

NDC 11822-8329-7

Compare to the active

ingredient of Children's

Claritin^® Chewables**

AGES 2 YEARS & OLDER

CHILDREN'S

ALLERGY RELIEF

CHEWABLE TABLETS • ANTIHISTAMINE

DYE-FREE

LORATADINE CHEWABLE TABLETS USP, 5 mg

NON-DROWSY* INDOOR / OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose • Itchy, watery eyes

Itchy throat or nose

ACTUAL SIZE

GRAPE

FLAVOR

30

CHEWABLE TABLETS

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING.

Advanced Ingredient Data

[{"name": "Loratadine", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "aspartame", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "anhydrous citric acid", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "silicon dioxide", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "mannitol", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "microcrystalline cellulose", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium starch glycolate type a potato", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "stearic acid", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.", "Other information": "phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).", "Inactive ingredients": "aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid", "Active ingredient (in each tablet)": "Loratadine USP, 5 mg", "PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton": "FREE FROM DYE FREE 24 HOUR NDC 11822-8329-7 Compare to the active ingredient of Children's Claritin ® Chewables** AGES 2 YEARS & OLDER CHILDREN'S ALLERGY RELIEF CHEWABLE TABLETS • ANTIHISTAMINE DYE-FREE LORATADINE CHEWABLE TABLETS USP, 5 mg NON-DROWSY* INDOOR / OUTDOOR ALLERGIES 24 HOUR RELIEF OF Sneezing • Runny nose • Itchy, watery eyes Itchy throat or nose ACTUAL SIZE GRAPE FLAVOR 30 CHEWABLE TABLETS *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL. THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING."}

dye-free children's loratadine chewable tablets usp, 5 mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information